Principal Biostatistician

📋 Description

• Write and review statistical sections of protocols
• Write and review statistical analysis plans including complex study designs
• Conduct statistical analyses and present results to project teams and sponsors
• Develop SAS programs for tables, listings, figures and analysis datasets
• Generate and verify randomization schedules
• Provide and verify sample size calculations, including adaptive design

🎯 Requirements

• Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years
• Experience with SAS
• Knowledge of ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
• Broad knowledge of advanced statistical concepts and techniques
• Preferred: Experience with Oncology and rare diseases
• Preferred: Broad experience with late phase and/or submissions